# Clin-Trans-Valid-IDI

> **NIH NIH U54** · JOHNS HOPKINS UNIVERSITY · 2021 · $183,477

## Abstract

Summary
Point of care (POC) diagnosis of sexually transmitted infections (STIs) can positively impact public health, the
healthcare system and patient-related outcomes. Laboratory-based STI diagnostic tests with long turn-around
times remain the standard of care in high-resource settings; the diagnosis often returns after the patient has
left the clinic compromising the provider's ability to ensure treatment and interrupt transmission. Syndromic
management continues to be the standard of care for STI treatment in low-resource settings and in emergency
departments and urgent care settings which leads to high rates of over and under treatment for those with
symptoms. Despite a number of new POC STI tests with functional prototypes, developers face significant
barriers to commercialization, which include limited access to patient samples for testing and appropriate
clinical care settings for performance testing. Getting feedback from end-users on prototypes and early designs
is also critical for evaluating tests in practice to accelerate adoption. Understanding how POC STI tests can be
integrated into clinical work flow to provide timely diagnosis without disrupting care could transform care for
STIs by allowing same-visit diagnostic certainty and targeted treatment. Specific barriers to implementation
include lack of data regarding performance characteristics of new tests in diverse settings and lack of provider
awareness of POC STI tests. We have developed methods and tools to evaluate POCT for STDs performance,
acceptability and usability of POC tests among end-users in diverse settings. The work of the Clinical
Translation and Validation Core will be guided by three Core aims: 1) To evaluate diagnostic accuracy,
usability and acceptability of prototype POC devices for STI diagnosis, 2) To describe and evaluate
implementation of POCT for STDs including end-users' assessment of preference, acceptability, usability, and
test experience. We will also assess the impact on patient and partners' health, behaviors and well-being as
well as the impact on healthcare delivery and/or public health outcomes, and 3) Develop a sustainable,
searchable STI Diagnostic Watch database for developers and end-users. Our Center allows developers at all
stages of the development pipeline to have one-stop shopping; from early iterative testing with samples from
our well-curated biorepository, to clinical testing in diverse settings including an urban emergency department,
an adolescent ambulatory clinic, a low-resource setting in Uganda, and by internet access with self-sampling.
We will address site-specific aims based on end-user needs particular to each site. This Clinical Translation
and Validation Core will accelerate development of new POC STI tests that will be accurate and rapidly
adopted.

## Key facts

- **NIH application ID:** 10159907
- **Project number:** 5U54EB007958-14
- **Recipient organization:** JOHNS HOPKINS UNIVERSITY
- **Principal Investigator:** Yukari C Manabe
- **Activity code:** U54 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $183,477
- **Award type:** 5
- **Project period:** 2007-09-30 → 2023-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10159907

## Citation

> US National Institutes of Health, RePORTER application 10159907, Clin-Trans-Valid-IDI (5U54EB007958-14). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10159907. Licensed CC0.

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